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White Paper

eCTD 4.0 Implementation Including Understanding of Regional Differences

eCTD 4.0 Implementation Including Understanding of Regional Differences

eCTD 4.0 Implementation Including Understanding of Regional Differences

IQVIA
Pages 14 Pages

This white paper explains how eCTD 4.0 modernizes global regulatory submissions beyond the limitations of version 3.2. The new standard introduces a more flexible, data-driven structure that improves lifecycle management, document reuse, metadata updates, automation, and long-term scalability. It supports more product types, allows one-to-many document replacement, reduces duplicate files, and enables controlled vocabulary changes without major system updates. The paper also outlines regional differences in submission structures, metadata, language support, worksharing, and transition requirements.

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